Metronomic Vinorelbine in Patients With Metastatic Tumors: Phase II Translational Study
The purpose of this study is to define the biologically optimal dose of vinorelbine when
administered at a metronomic dosing schema. [Metronomic chemotherapy refers to the close,
regular administration of minimally toxic doses of cytotoxic drugs, with minimal or no
drug-free breaks, over prolonged periods]. Patients with recurrent or metastatic solid
tumors are randomly assigned one of three different doses of oral vinorelbine (30 or 40 or
50 mg). Treatment is administered three times a week (Monday, Wednesday and Friday)
continuously until disease progression or unacceptable toxicity or to a maximum of 24
months.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
time to treatment failure
TTF rates per arm will be compared at 4 and 6 months
Yes
Evangelos Briasoulis, MD
Principal Investigator
Assistant Professor of Oncology, Medical School, University of Ioannina
Greece: Ministry of Health and Welfare
HE 50/05
NCT00278070
January 2006
February 2008
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